Centers for Disease Control & Prevention EHDI Grants (2000):
Colorado

GRANT ABSTRACT
• Grant Narrative

GRANT NARRATIVE

UNDERSTANDING THE PROBLEM

Concise understanding of the requirements and the purpose of the cooperative agreement: Hearing loss is one of the most common congenital disorders in the United States.  Approximately 12,000 infants are born every year with significant hearing loss that undetected can cause significant delays in language and cognitive development (1).  Over the past decade, numerous agencies have endorsed universal newborn hearing screening (2,3,4,).  Currently 28 states have passed legislation requiring universal newborn hearing screening.  Colorado has demonstrated that infants born in hospitals that provide newborn hearing screening were identified with hearing loss at the average age of 3 months.  Conversely, children born in hospitals that did not provide a newborn hearing screen were not identified until an average age of 23 months.  The language outcome of the infants born in screening hospitals was statistically improved over the infants born in hospitals that did not screen (5). However, it is recognized that screening alone will not provide the outcome of early identification and intervention. States need to develop comprehensive systems of care from screening to diagnosis and into early intervention. Research has demonstrated that systems must accomplish diagnosis and early intervention during the first six months of life in order to achieve normal language (6).  Thus, Healthy People 2010 goals calls for hearing screening for all infants by 1 month of age, identification of hearing loss by 3 months of age and intervention by 6 months of age (7).

In 1997, the Colorado Legislature passed House Bill 97-1095 requiring Colorado hospitals to establish newborn hearing screening programs.  The Colorado Department of Public Health and Environment (CDPHE), Health Care Program for Children with Special Needs (HCP) manages the Colorado Newborn Hearing Screening Program and the Colorado Home Intervention Program (CHIP).  CHIP is the statewide parent centered early intervention program for infants and children, birth through three years. Currently, all Colorado birthing hospitals offer a newborn hearing screening to all infants prior to hospital discharge.  After more than 10 months of full implementation of the newborn hearing screening program gaps in the follow-up system have been identified for infants who are missed, infants who are transferred or for infants who fail the screen. The legislation requires that infants who fail a screening receive timely and appropriate follow-up services to assure the positive outcome of language development.  The Colorado Infant Data Management System tracks infants from screening through early intervention. 

In addition, the Colorado Department of Public Health and Environment (CDPHE) manages other newborn screening and monitoring systems (Newborn Genetic Screening, Colorado Responds to Children with Special Needs, Early Periodic Screening, Diagnosis and Treatment Program) that could be better coordinated with the Colorado Newborn Hearing Screening Program.  This project also provides an opportunity to better integrate these data systems with IRIS, the Integrated Registration and Information System that manages client information from the Early Periodic Screening, Diagnosis and Treatment Program (EPSDT) and the Health Care Program for Children with Special Needs (HCP).

The “Cooperative Agreement for Early Hearing Detection and Intervention (EHDI) Tracking, Research, and Integration with Other Newborn Screening Programs” will provide the opportunity for states to strengthen EHDI programs.  Improved collaboration and integration with other state newborn programs such as the Newborn Genetic Screen (blood spot), Colorado Responds to Children with Special Needs (birth defects monitoring and prevention program) and the Early Periodic Screening, Diagnosis and Treatment Program (EPSDT) will allow for more integrated tracking and follow-up of infants with disabilities.  Colorado Responds to Children with Special Needs (CRCSN) currently includes children with hearing loss and children with conditions identified by the Newborn Genetic Screen. CRCSN also includes a referral and notification system and collects information on children up to age three years of age.  An integrated data system will also provide more efficient systems at the local level to prevent duplication of care coordination efforts between programs for families.

The goals of the proposal will be to: 1) eliminate gaps in tracking and follow-up of children who are deaf or hard of hearing and improve the coordination and efficiency of diagnostic and intervention services for these children by automating the data system; 2) improve the efficiency of data flow between the Colorado Newborn Hearing Screening Program, the Colorado Home Intervention Program, the Newborn Genetic Screening Program, Colorado Responds to Children with Special needs (CRCSN) through IRIS: and 3) identify and follow a cohort of children with specific conditions identified by the Newborn Genetic Screening Program in order to evaluate the effectiveness of the follow-up system.

Challenges, barriers and problems associated with developing and implementing EHDI tracking and surveillance: In general, there are many challenges to creating a comprehensive, community based culturally sensitive system for EHDI programs.  In order to provide a comprehensive program all birthing hospitals must screen prior to hospital discharge.  The challenges for hospitals include: identifying funding resources to purchase equipment; determining which technology will yield the highest sensitivity and specificity; identifying personnel to implement the screening program; providing education to physicians and families; obtaining reimbursement for the screening procedure; identifying a follow-up protocol for infants who fail the screen, are transferred or are missed; maintaining a data management system for quality assurance, tracking and follow-up; providing screening results to the infant’s medical home and other related agencies such as departments of health and Part C of the Individual Disabilities Education Act.

When an infant fails the screen, there needs to be a clear concise protocol for follow-up.  The protocol should address those factors that have been shown to impede follow-up.  The factors include: lack of understanding of the recommendations; cultural barriers; language barriers; lack of transportation; lack of funding; lack of physician compliance; parent denial; poor tracking and data management systems.

Comprehensive audiological and medical assessments are required to manage the infant’s care when a hearing loss is suspected.  Barriers in this arena include lack of skilled pediatric audiologists within the community; lack of physician education to understand the issues; lack of funding for appropriate assessments.  Early intervention programs face similar challenges: lack of skilled therapists in the arena of infant hearing loss; lack of community based services; and funding for early intervention services.

Developing a statewide data management and tracking system beginning with the hospital screening programs will assist in assuring that infants receive timely and appropriate follow-up services.  Data management and tracking systems must be available to hospitals, medical homes, audiologists and early interventionists.  The current challenge is linking data systems with all of the providers and maintaining confidentiality.  The CDC Cooperative Agreement will give states the opportunity to develop a comprehensive data system between several screening and surveillance programs.

Current status of the Colorado Infant Hearing Program including current statistics: Colorado has approximately 63,000 births per year.  Currently all 56 birthing hospitals offer a newborn hearing screen either prior to discharge or within two weeks of birth (there are six rural hospitals that rotate two pieces of equipment every two weeks) which accounts for 99% of the birth population.  Attachment C lists the participating hospitals as well as the 1999 statistics.  In 1997, the Colorado Legislature passed House Bill 97-1095 requiring hospitals to implement newborn hearing screening programs (Attachment A, pg. 1-6) The Colorado Department of Public Health and Environment (CDPHE), Health Care Program for Children with Special Needs (HCP) is the agency responsible for the Colorado Newborn Hearing Screening legislation.  The legislation required the development of an advisory board which is responsible for developing guidelines (Attachment B, pg.12-44) to assure appropriate and timely follow-up for infants and their families.  The Colorado Infant Hearing Advisory Committee meets quarterly to address the challenges of implementing a comprehensive, community based EHDI Program.  This interdisciplinary team is composed of physicians, audiologists, hospital representatives, health department staff, Part C staff, early interventionists, parents and consumers who are deaf and hard of hearing (Attachment B, pg.7-8).  Four task forces have been created to develop guidelines and address concerns in the areas of screening, audiologic assessment and amplification, early intervention and medical follow-up (Attachment B, pg. 9-11). 

In addition to the advisory committee, HCP has 3 part time FTE.  The State Audiology Consultant who serves as the Coordinator for the Colorado Newborn Hearing Screening, the Director of the Colorado Home Intervention Program (CHIP) and the Colorado Hearing Resource (CO-Hear) Consultant. The Colorado Home Intervention Program is the only statewide program for specifically for children who are deaf and hard of hearing, birth through three years of age. HCP also has 13 regional offices, each with a designated part time Audiology Regional Coordinator and Colorado Hearing Resource (CO-Hear) Coordinator.  The primary responsibilities of the Audiology Regional Coordinator is to work with the local hospitals in developing a community based protocol for follow-up from the newborn hearing screen to early intervention.  The Audiology Regional Coordinator also monitors the hospitals program for quality assurance (e.g. number screened, refer rates, number missed, number returned for follow-up).  The CO-Hear Coordinator provides care coordination for funding and services when a child is diagnosed with a hearing loss.  The Audiology Regional Coordinators and the CO-Hear Coordinators work directly with the State Audiology Consultant, the Director of the Colorado Home Intervention Program and the CO-Hear Consultant.  The scopes of work are included in Attachment D, pg. 48-64 and Attachment I, pg. 107-110 demonstrates the organizational structure for the CDPHE and HCP.  The Audiology Regional Coordinators and the CO-Hear Coordinators provide education and training to local audiologists and early intervention program.  Audiologists and early intervention programs were identified through a needs assessment performed by the Colorado Department of Public Health and Environment in collaboration with the Marion Downs National Center for Infant Hearing at the University of Colorado. 

The Colorado Infant Hearing Program has a comprehensive protocol for screening through early intervention (Attachment B, pg. 15).  The Colorado Newborn Hearing Screening Program brochure (Attachment E, pg. 65-66) is given to every parent prior to the newborn hearing screening explaining the procedure; the importance of follow-up recommendations; and the need for ongoing monitoring of their child’s hearing, speech and language.  The Audiology Regional Coordinators work with the hospitals to provide information at the birthing classes, thus informing parents of the screening prior to admission.  Parents are also informed that the results of the screening will be sent to the CDPHE for monitoring and tracking purposes.  Hospitals that contract with an outside agency to provide the screening also require a separate signed informed consent. 

The Department of Health Statistics and Vital Records has collaborated with the Colorado Newborn Hearing Screening Program and the Newborn Genetic Screening Program.  The electronic birth certificate populates data for the Newborn Genetic Screening Program by linking the birth certificate to the information on the incoming laboratory blood spot specimens drawn at birth.  Eventually, this linkage will allow distinguishing first from second screen on blood spot for each individual.  This is important as Colorado recently made a decision to screen twice, at birth and at 10 days to two weeks of age.  It will also eventually make clinical follow-up more efficient and complete, as it will be helpful in clarifying the variety of name changes that occur between the first day of life and the time at which the birth certificate is filed.  This is also an issue for the Newborn Hearing Screening Program. For the Colorado Newborn Hearing Screening Program, fields have been added to the electronic birth certificate software (Attachment F, pg. 67-101) to document the results of the hearing screening for each ear and a reason if a newborn hearing screen was not completed (e.g. transferred, missed, deceased, parent refused).  This information is then modemed to HCP.  The screening information from the electronic birth certificate populates the comprehensive software program, the Colorado Infant Hearing Data Management System, which has been developed to track infants from hospital screening to diagnosis and through early intervention.  A comprehensive description of this data management system is found in Attachment F. The data program tracks and monitors the screening programs in the hospitals.  The Colorado Infant Hearing Advisory Committee encourages hospitals to bring infants back to the hospital within two weeks of discharge if they have did not pass the hearing screen.  Currently Colorado has the lowest documented refer rate at discharge of less than 3 percent statewide.  By adding a second stage outpatient screen this reduces the number of infants who receive more costly diagnostic evaluation to less than 1 percent.  The “Hospital Monthly Tracking and Summary Report Forms” are sent to the hospital that includes the names of infants who did not pass the screening in either ear prior to discharge or who were missed, transferred, deceased or parents refused.  Hospitals manually update and return these forms with screening results on infants who have returned for outpatient follow-up.  Hospitals can also indicate on the Report Form if infants have been referred to an audiologist, primary care physician or if they are lost to follow-up.  The infants name will remain on the Report Form until there is an indication that follow-up has occurred.  The local HCP offices have access to the Monthly Report Forms to work directly with hospitals and physicians at the local level and assist in tracking infants through the process of screening to diagnosis.  Current statistics (Attachment C, pg. 46-47) document the percentage of infants screened, referred for follow-up, returned for follow-up, and infants identified with hearing loss.

A family can be referred directly to an audiologist from the hospital program or by the primary care physician.  Audiologists are required to submit a Follow-up Hearing Form (Attachment F, pg.68) on every infant, regardless of the screening outcome, to HCP for the Colorado Infant Hearing Data Management System.  The Follow-up Hearing Form is also completed on older children diagnosed with hearing loss to monitor late onset or progressive hearing losses.  The Colorado Infant Hearing Advisory has developed guidelines for physicians to monitor infants who are high risk for progressive hearing loss or late onset of hearing loss (Attachment B, pg.18-26). When an infant is diagnosed with a hearing loss, signed informed consents and releases of information are obtained from the family so that early intervention and support services can begin.  The diagnosing audiologist contacts the CO-Hear Regional Coordinator to begin the transition into early intervention services.

Colorado Hearing Resource Coordinators (CO-Hear) are located regionally throughout the state to work with families immediately after diagnosis.  Although they receive their referrals primarily from audiologists, they may also receive referrals from physicians, Part C Coordinators, Child Find Coordinators and EPSDT case managers.  The CO-Hear Coordinators complete and submit and intake form on each family (Attachment F, pg. 69) to HCP for the Colorado Infant Hearing Data Management System.  The CO-Hear Coordinators provide families with unbiased information about language options, funding resources and parent support networks (Attachment B, pg. 15, 129-141). The family can select a program that works specifically with very young children who are deaf and hard of hearing or a non-categorical early intervention program.  Families are encouraged to select the program that meets their needs and the developmental needs of their child.  If the family chooses to receive services from the Colorado Home Intervention Program (CHIP), the largest statewide program that operates through HCP, the CO-Hear Coordinator will continue to be involved with the family.  If the family chooses another early intervention program, the CO-Hear’s participation with the family as a service coordinator, a resource for funding, and/or a consultant is always available on parent request.  Often, the Part C agency asks the CO-Hear Coordinator to stay involved with the family when a hearing loss is identified.  The CO-Hear Coordinator has expertise in this field and is fully aware of Part C regulation, procedures and protocols.  The CO-Hear Coordinators also obtain releases of information from the family so care coordination between agencies such as the Part C and the Developmental Disabilities Centers.  At an active member of the Part C Program, the CO-Hear ensures that each family is aware of Part C and that Part C knows the family’s Individualized Family Service Plan (IFSP) has been completed.

The Colorado Home Intervention Program works collaboratively with the University of Colorado to monitor the outcomes of infants and children diagnosed with hearing loss. The importance of using developmental profiles for the purpose of monitoring the progress of children with hearing loss has been documented.  Subsets of the developmental profiles are also being added to the Colorado Infant Hearing Data Management System.  Another goal of this grant would be to increase data flow between Part C and other early intervention programs for the purpose of maintaining data on all children who are deaf and hard of hearing.

Hands and Voices are a statewide parent organization to provide parents support regardless of their communication choice.  The University of Colorado was recently awarded a Maternal and Child Health Grant that will strengthen parent participation (Attachment G, pg. 102-103).  Regional Parent Coordinators are being identified at the local level, who has an infant or child who is deaf and hard of hearing.  The will work with the CO-Hear Coordinator and the Audiology Regional Coordinator to assure comprehensive, culturally sensitive, community based systems of care for infants and their families from screening through intervention.  Parents who choose to participate in Hands and Voices are also kept on the Colorado Infant Data Management System.

Although the electronic birth certificate and the Colorado Infant Hearing Data Management System assist HCP in tracking infants it does not “assure” that families will bring infants back in for follow-up.  One of the largest barriers for the Colorado Infant Hearing Data Management System for follow-up is that it relies on manual tracking between HCP, the outpatient screenings, the audiology diagnostic centers, the physician and the early intervention programs.  A primary goal of this grant would be to automate the tracking between hospitals, audiologists, CO-Hears, early intervention programs and medical homes.  The increased data flow between the Newborn Genetic Screening Program, CRCSN and EPSDT will strengthen the ability to monitor screening and follow-up activities for infants who are at risk.  The collaboration of these Programs will provide a comprehensive follow-up system for children with special health care needs by allowing the local health departments and HCP offices assist hospitals and physicians with follow-up process and decrease duplication between Programs.

Willingness to integrate EHDI surveillance and tracking system with other newborn screening program activities: The Colorado Newborn Hearing Screening Program, through the Health Care Program for Children with Special Needs (HCP) has letters of support (Attachment K, pg.142-148) from the Newborn Genetic Program, Colorado Responds to Children with Special Needs (CRCSN), and the Early and Periodic Screening, Diagnosis and Treatment (EPSDT) Program to collaborate and integrate data programs and functions at the state and local levels. There is also support to integrate the data system on to the Integrated Registration and Information System that manages client information for HCP, EPSDT, CRCSN and the Newborn Genetic Screen. Currently Follow-up Hearing Loss Reports are also sent to CRCSN, however this is a manual system.  This grant would automate this type of data flow between CDPHE Programs.

The Newborn Genetic Screen, CRCSN, and EPSDT are represented on the Colorado Infant Hearing Advisory.  The collaboration between these departments is already in place.  Currently there is a CDC grant through CRCSN to improve the ability of families and community providers to access appropriate interventions and services for children affected by congenital hearing loss.  A description of the grant activities is located in Attachment H.

GOALS AND OBJECTIVES

The goals and objectives for both Level I and Level II, Option 2 are outlined in Chart 1 of the narrative, pg. 31-34.  All Level I activities for the Colorado Newborn Hearing Screening Program will be maintained or refined as needed.  The Colorado Department of Public Health and Environment meets the CDC requirement of inclusion of women, ethnic and racial groups in the proposed project.

DESCRIPTION OF PROGRAM AND METHODOLOGY

Description of Target Region and Number of Births Per Year in Region: Enclosed is a map of the state of Colorado, the target area for the proposed project (Attachment I, pg.106).  Colorado has a diverse population that includes Hispanic/Latino, African American, and Asian communities located in rural, frontier and urban regions of the state.  Currently, there are 63,000 births per year in the state of Colorado.  Of that number, 87percent of the infants have been screened in the last ten months since the newborn hearing screening program has been fully implemented.  Of the babies born in Colorado, 99 percent have the opportunity to receive a hearing screening before hospital discharge if they are birthed in designated birthing hospitals. We anticipate the number of infants screened will continue to rise with the birth rate in this state and improved tracking for those babies missed and birthed outside of hospitals (e.g. home births). Of the number screened, we expect that we will identify 2 infants out of every 1000 births each year with permanent bilateral hearing loss and 1 infant out of every 1000 births each year with permanent unilateral hearing loss.

The populations that we target in this project are all Colorado newborns, those screened for hearing loss in the hospital, those identified with hearing loss, and those referred for intervention.  Similarly, this project targets, as a demonstration population, those infants that have been screened through blood spot and birth defects surveillance for PKU and hemoglobinopathies (mostly sickle cell disease).  It is anticipated that there will be 1-4 infants identified with PKU and 7-10 with hemoglobinopathies.  Once data is brought under management for the above groups (year 1), the project will investigate monitoring infants identified through blood spot screening for congenital adrenal hyperplasia, hypothyroidism, galactosemia, biotinidase deficiency and cystic fibrosis (Years 2-5).

In Colorado, the success of the newborn hearing screening has increased the number of infants identified with hearing loss while decreasing the age at which they are identified.  Of those children who are identified for hearing loss, 65% of infants return for recommended re-screens and or diagnostic evaluations.  While this statistic compares favorably to the national average of 50 percent, it is still a core issue that we continue to address.  Additionally, the problems that have been identified with intervention are with timeliness and adequacy of follow-up due to the absence of a virtual medical home and coordination with other providers.

Current Services: The Colorado Department of Public Health and Environment (CDPHE) houses the Colorado Newborn Hearing Screening Program, the Newborn Genetic Screening Program, Colorado Responds to Children with Special Needs (CRCSN), and the Early Periodic Screening, Diagnosis and Treatment Program (EPSDT).  There is a strong history of collaboration among these programs and each is represented on the Colorado Infant Hearing Advisory Committee (Attachment B, pg. 7-9).

There is also strong collaboration of these Programs at the local level across the State of Colorado. EPSDT is a federally- required Medicaid program, designed to detect and treat health problems early among children birth through 21 through regular medical, dental, vision and hearing screenings.  In Colorado, the EPSDT outreach and case management is contracted though the CDPHE.  In turn the CDPHE contracts with local public health authorities in all 63 counties to provide these services through over 100 paraprofessional case managers.  These individuals provide a crucial link between vulnerable families and local health care systems, by encouraging families to access preventive health services, assisting them in accessing appropriate treatment services and by linking them with enabling services such as transportation and translation services.  EPSDT is in the process of being added to the Integrated Registration and Information System for case management statewide.

The Health Care Program for Special Needs has 14 Regional Offices also located within local public health authorities.  These offices each have a multidisciplinary team consisting of a Colorado Resource Hearing Coordinator, Audiology Regional Coordinator, Physical Therapy/Occupational Therapy Coordinator, Nutrition Coordinator, Nurse Coordinator, Speech Coordinator and Parent Coordinator.  The multidisciplinary teams provide comprehensive care coordination for children with special needs.  The Regional Offices participate in their communities Part C and DDC Programs through the Interagency Collaborative Council.  The roles of the Audiology Regional Coordinator and the CO-Hear Coordinators were previously described.  The HCP Regional Offices are also linked to the Integrated Registration Information System (IRIS) statewide.

All newborns are screened by a heel stick blood spot for PKU, biotinidase deficiency, galactosemia, hemoglobinopathies, hypothyroidism and cystic fibrosis.  On July 1, 2000, congenital adrenal hyperplasia will be added to the panel.  These screens are done at the CDPHE laboratory, the results down loaded to the Family and Community Health Services Division (FCHSD) where a fulltime FTE is responsible for assuring clinical follow-up for all infants with an initial positive screen for the diseases listed above.  There are six Genetic Counseling Clinics that are located throughout the state through The Children’s Hospital and University Health Sciences Center.  The Genetic Clinics work closely with Dr. Letson, the medical director of the newborn genetic screening program.  These Clinics evaluate families for genetic risk and are given appropriate counseling.  Families are seen by a medical geneticist and a genetic counselor.

CRCSN has developed a program, the Community Notification and Referral Program (CNRP); to prevent secondary disabilities in identified children by connecting their families with services and supports in their local communities.  CNRP is a collaborative venture with local health departments, community nursing services and early childhood agencies. In order to connect children and families with local services, CRCSN works with local public health and early childhood agencies who contact the families.  A representative from the agencies links the families to Child Find coordinators for developmental screening and evaluations or to other services and supports, as needed by the family. The Colorado Department of Education has sponsored the growth of community systems to identify and assist infants, toddlers and families eligible for assistance through the federal Individuals with Disabilities Education Act (IDEA) Part C, which focuses on young children.  The conditions eligible for CRCSN included Colorado's original Part C eligible conditions although the conditions eligible for Colorado IDEA funding and services have changed over the years.  Even though children who are eligible for services under IDEA make up only a portion of children who are at-risk for developmental delay or who are identified by CRCSN, all families and children have benefited from these stronger community systems. 

CRCSN data are strictly confidential.  Parents control the release of information about their children.  Local agencies can release identifying information on a child to another agency only with the written permission of the parent, however, parents can inquire about and access these services themselves at any time.  Therefore, many agencies choose to inform families of the services and opportunities available and then encourage the families to contact the services directly. CRCSN operates under statutory mandate (C.R.S. 25-1-107) and regulatory authority (C.C.R. 1009-7) to collect information regarding conditions such as birth defects and developmental disabilities.  The confidentiality of the information is protected by C.R.S. 25-1-122.  The same confidentiality statutes bind local agents. Release of information from birth certificates is restricted by statute (C.R.S. 25-2-117).  The parents or guardian of a child identified through a birth certificate are sent a letter from the State Registrar of Vital Statistics notifying them that their child may be eligible for services and requesting them to return the letter if they do not wish to be contacted by a local agency.

The parents or guardians served by a non-public health agency (currently in Arapahoe, Denver, Douglas, Jefferson, Pueblo and Weld Counties) are sent a letter from CRCSN similar to the birth certificate negative consent letter. Each agency receives and returns information concerning the child on a Notification Form.  Information provided to the agency includes the child's name, date of birth, address and parent or guardian's name plus phone number when available.  The reported diagnoses, the date of each diagnosis, the source of the eligible diagnoses (birth certificate, hospital discharge, etc.), the hospital where the diagnosis was made and the length of stay are also provided. The representative from the local agency completes the form and returns it for tracking and evaluation purposes indicating whether the agency already knew the child. The registry includes birth defects, developmental disabilities and risks for developmental delay.  Therefore, it includes children who have conditions, which may not require developmental screening, or public health intervention or which will not lead to developmental delays. The CNRP has grown and changed since its inception in 1990.  Both the number of communities participating and the number of children referred to the local agencies have increased.  The original fourteen counties received information on 712 children in 1990.  By 1999, 61 counties were receiving information on over 1,600 children.

Project’s Addressing of Program Requirements related to Levels I and II (option 2): The goals and objectives for Level I activities are found on Chart 1, pg. 31-34.

Level I: The CDPHE is committed to maintaining the activities described for Level I.  The CO-PI for the project, Vickie Thomson, who is on staff at CDPHE as the Audiology Consultant would supervise these requirements for tracking the EHDI program.

Level I, h. Integration of other screening programs that identify children with special health care needs such as newborn blood spot screening and birth defects surveillance: As a result of activities related to a state genetics planning grant we have started design work in the past year on a template for integration of data systems that include newborn blood spot screening, newborn hearing screening, birth defects registry, Early Periodic Screening Diagnosis and Treatment data, and data on children in Colorado’s Health Care Program for Special Health Care Needs Children (HCP).  Prior to this, a system had been under design and revision that was intended to be useful as a data compilation and storage tool as well as a case management tool.  This system is called Integrated Reporting and Information System (IRIS).  IRIS has both data fields and space for narrative that can serve as a partial medical record for case management purposes.  In accordance with this, the project proposes to improve the data flow between the newborn blood spot screening, the birth defects surveillance program (CRCSN).  In Colorado all newborn blood spot screening is done by the CDPHE Laboratory and Radiation Services Division (LARS) and follow-up is coordinated by an individual located within the Family and Community Health Services Division (FCHSD) of CDPHE.  The follow-up activity is directed by the CO-PI, Dr. Letson who also oversees contracts with The Children’s Hospital in Denver for clinical follow-up of children with disorders identified by the newborn blood spot screens.  Pediatric sub-specialty services for diseases identified by these screens are only available at The Children’s Hospital/University of Colorado Health Sciences Center in Denver.

One objective of this proposal is to improve the efficiency of the data flow between newborn hearing screening, newborn genetic screening, and IRIS by automating the sequence of blood spot screening and identification of an abnormal specimen, notification.  We would refine a template for integrating data systems for the above programs plus Early Periodic Screening Diagnosis and Treatment and the Health Care Program for Children with Special Needs. The data for the above programs would be integrated electronically rather than manually.  The unique components of each system would be identified and incorporated into a program representing data flows and decision trees.  The project would request funding for the committed time from CDPHE Information Technology Service (ITS) programmers to make this design an electronic reality.  This template would be the preliminary step to improving the integration of data, which is compiled and stored in the Integrated Registration Information System (IRIS) and used for case management by field Public Health Nurses.  Other objectives are to: create a virtual medical home for identified children which includes immunization history, and to design the necessary internet platform bases for integration and a virtual medical home which would include the necessary programming and security safeguards and requirements for entry into the database and individual records.

In the past year we have already undertaken to expand the capacity of IRIS to accommodate more than HCP data and include information from the other above named data sets so that individual clients with specific or potential diagnoses from those data sets can be integrated into IRIS for case management purposes electronically rather than manually which has been the entry mode in the past.  Our efforts have consisted of identifying unique components of each of the data systems and then designing schematics that represent the data flow and electronic decisions trees through which the original data set items must flow into appropriate areas of IRIS.  The pathways are similar but differ somewhat based upon the unique features of the data set of origin.  One critical item missing from this effort currently is the committed time from CDPHE Information Technology Service (ITS) programmers to make our schematic designs electronic reality.  This requires identified and committed funding for ITS personnel.  Small funding streams have been used for brief periods of work (one year or less) but the demands on ITS are so significant that funding commitments for less than a three year period puts any project at risk of losing its programming experts from ITS to a project that has a higher priority based on consistency and longevity of funding.  This grant, if approved, would provide the type of consistent funding needed to accomplish the above noted objective of integrating the different data systems with IRIS.

A second issue is that of proceeding with the work of making all or parts of the above data sets available on Internet platforms and designing the appropriate security safeguards so that one could create a virtual medical home.  This is important as no matter how hard we try to establish medical homes for all children, the reality persists that many and especially many high-risk patients either do not understand the need for or are not able to comply with this goal.  In addition, the current climate with regard to Managed Care in medical care results in frequent changes in the “medical home” provider.  A “virtual medical home” would create an accessible database for infants in universal screening programs and/or children with special health needs.  Providers in a setting where a child had not been previously seen or had no identified primary care provider could access critical information related to that child’s care from these Internet databases with the proper password or combination of passwords.  This system could obviously also include immunization information.  Again, the funding from this grant would make this work possible.

The applicant will improve efficiency of data flow between newborn hearing screening, new born blood spot screening, EPSDT, HCP, the birth defects registry and IRIS by securing the needed programming commitment from ITS.  This will be accomplished in the first year of the grant.  The applicant will also design the necessary components of Internet platform data bases for newborn blood spot screening, newborn hearing screening, immunizations and birth defects surveillance.  This design would include necessary programming and security safeguards and requirements for entry into the database and into individual records.  This would be a second and third year grant activity.

Level II, Option 2, a. Inclusion of two conditions in cohort for monitoring: In conjunction with the above programs, the Sickle Cell Center, the Inherited Metabolic Diseases Clinic at The Children’s Hospital and the CDPHE Laboratory and Radiation Services (LARS), the above programs will identify a cohort of children with PKU (1-4/year) and hemoglobinopathies (mostly sickle cell disease (7-10 per year) who would be followed prospectively.  A representative located within the Family and Community Health Services Division, CDPHE and The Children’s Hospital in Denver does follow-up.  In addition, records from the FCHSD newborn screening follow-up program and SC and IMD clinics will be cross referenced with the Colorado Responds to Children with Special Needs registry to further case ascertainment.  To determine adequacy of patient follow-up and medical management, a retrospective cohort of all patients identified with PKU and Hemolglobinopathies will be identified for the five years proceeding the present.  Their location will be determined, identify of primary care providers and permission obtained for chart review to determine adequacy of medical management.  This will involve roughly 55 patients, 15 PKU and 40 with Sickle Cell.  This method of follow-up and review will be incorporated into the prospective cohort of patients identified by newborn blood spot screening from the time of onset of the grant cycle.

Level II, Option 2.b Plan for integrating EHDI tracking system to determine effectiveness: The project would monitor adequacy of follow-up by matching records of identification and referral with patients getting treatment in the Sickle Cell and Inherited Metabolic Diseases Clinic.  After demonstrating successful integration with screening programs for small populations, it will include screening programs for larger populations such as cystic fibrosis, biotinidase deficiency, hypothyroidism, galactosemia and hypothyroidism.

Infants (120/year) identified as having true congenital hearing loss will be referred to the Genetics Counseling Clinics that are located throughout the state of Colorado.  Families will be evaluated for genetic risk and given appropriate counseling.  The CO-Hear Coordinators and local audiologists will also meet with families, at these Clinics, to provide a multidisciplinary evaluation.  Infants will be tracked by the Colorado Infant Hearing Data Management System.  Audiology Regional Coordinators and the Co-Hear Coordinators will monitor programs at the local level for referral to itinerant genetics clinic, local audiologists and Part C of IDEA. They will identify the adequacy of referral to the itinerant genetics clinics from The Children’s Hospital, local audiologists and part C of IDEA.  These activities will be coordinated by the Program Data Manager position to be located in the HCP section of FCHSD at CDPHE.

Infants identified by newborn blood spot screening with congenital adrenal hyperplasia (6/year), hypothyroidism (20-23/year), galactosemia (1/yeaar), biotinidase deficiency (2/year) and cystic fibrosis (15-17/year) will be followed in a fashion similar to that described for PKU and hemoglobinopathies.  This will be a second/third year activity and will be done in conjunction with IMD, Pediatric Endocrine and Pediatric Pulmonary clinics at The Children’s Hospital.

Level II, Option 2, c. Plan for documenting services received and the condition for each affected child in cohorts: By using the data entered into IRIS as described in Level 1h, we will be able to asses the adequacy of case management activities in terms of whether the children have an established medical home, necessary specialty referral services and whether they actually access those services and how often.  We will also be able to track the effectiveness of intervention/case management by assessment of whether problems recorded in IRIS are resolved or not.  In some cases where a problem may never resolve entirely, success could be measured by changes in the frequency with which visits for a given problem occur.

By using the data entered into IRIS as described above the project proposes to assess the adequacy of case management activities measured by the existence of a medical home, necessary referral services utilization of services (when and how often).  It will be possible to track effectiveness of services according to recorded problems and resolution of problems in IRIS.  For ongoing, chronic problems, the effectiveness can be measured by the frequency of the visits. 

Level II, Option 2,d.  Collaboration with other Level II recipients: Option 2d: CDPHE is headquarters for the Mountain States Genetics Network.  Dr. Letson is Director of that Network.  There is a history of good collaboration on issues relating to genetics in general including newborn screening in this six-state region (Arizona, Colorado, Montana, New Mexico, Utah and Wyoming) (Attachment K, pg.159).  In addition a recent project within the region has expanded to include the Texas regional network and is exploring a similar collaboration with the southeastern region head quartered in Atlanta.  This project is one that has developed clinical guidelines for the management of Sickle Cell Disease that will become a standard in those participating regions.  This example of interstate collaboration could easily be applied to other Level II/Option 2 recipients and there is some likelihood that some of those recipients may already be involved in the above noted project.  We would pursue these efforts in the same fashion that has been successful in this region and in addition solicit the help of the National Newborn Screening for Genetics Resource Center, under the direction of Dr. Brad Therell in San Antonio, Texas (Attachment K, pg.151).  Exploration of collaborative opportunities between grant recipients would be a first year activity.

Vickie Thomson, M.A. is past president of the Directors of Speech and Hearing Programs in State Health and Welfare Agencies.  The DSHPSHWA members are typically responsible for newborn hearing screening programs in their state MCH/Title V Programs.  They have worked collaboratively to develop programs on newborn hearing screening.  The Center for Disease Control and members from DSHPSHWA developed a task force that established standardized data sets.  These data sets include: number of live births; number screened prior to discharge and before one month of age; number referred for diagnostic evaluation; number with diagnostic audiological evaluation by 3 months of age; number pending; number of children with permanent congenital hearing loss; average age in months of diagnosis of hearing loss; number of infants enrolled in intervention by 6 months of age.  The Colorado Newborn Hearing Screening Coordinator, Vickie Thomson, participated on the task force and provides data to the Centers for Disease Control, EHDI Program.  The information obtained from the electronic birth certificate, the Follow-up Hearing Reports and the CO-Hear Intake Forms provide the needed information for the above data sets.  This allows the CDPHE to obtain outcome data for monitoring hospital programs (e.g. refer rates, screen rates, return for follow-up) as well as outcomes for children identified through the Colorado Newborn Hearing Program.  Colorado Infant Hearing Data Management Software is currently undergoing enhancements, however when complete several states are interested in using it for their programs.  The CDC Cooperative Agreement would allow Colorado to enhance the Colorado Infant Hearing Data Management System and make it available to other states and territories.

Methods Used To Carry Out Activities: This is a summary of the activities proposed in the project.  The project personnel would eliminate gaps in follow-up and tracking for children identified through a variety of programs by facilitating data collection, analysis, integration and flow .The project CO-Principal Investigators would hire a Project Data Manager, a Project Coordinator and access personnel and services of the CDPHE Information Technology Service.  Specifically, the data systems would be improved and designed to provide information on the effectiveness of intervention and case management for identified children.  The detail for accomplishing this on a timeline, with identified persons and programs and preferred outcomes is included in the Goals and Objectives Chart, pg. 31-34.  The chart also serves as an action plan for the project.

EVALUATION PLAN

The strategies for organizational, operational and implementation strategies are in the goals and objectives chart 1.  Evaluation of the project’s effectiveness will occur on two levels – screening newborns for hearing loss, audiologic evaluation to identify healthy infants with hearing loss, and early intervention of identified children and resulting health improvements.  We will also evaluate the effectiveness of collaboration among programs/providers of services.

To measure the infant and children’s increases in screening identification and early intervention, Dr. Letson, and Ms. Thomson, CO –PI,’s will assist in the design and implementation of a system which will expand the capacity of the current IRIS system to include information from the above named programs for case management purposes. 

The finalized action plan, described in Goals and Objectives, will offer checkpoints for timeliness, responsible persons and programs and preferred outcomes.  The information available from the proposed integrated system would be evaluated by the individual users involved with reviewing reports and case management.

Information will be recorded throughout the intervention process.  Data will be compiled, synthesized and reported on an annual basis to CDC by the Project Data Manager. 

To measure the effectiveness of the collaboration among programs and the overall program, we will gather input from EPSDT, CRCSN, Newborn Genetic Screen, Newborn Hearing Screening Programs, as required during the cooperative agreement period.  There will be a mechanism in place for periodic feedback and program modification.  Quarterly meetings among programs/providers of services, written surveys and reviews by the CO-Principal Investigators and the Project Data Manager will be utilized to generate these reports. 

COLLABORATIVE EFFORTS

Methods for collaboration with hospitals, diagnostic centers, and intervention services: Letters of support/assurances from the hospital association, audiology and medical diagnostic centers and early intervention programs, including Part C are in Attachments K.  There are several ways that the project will collaborate.  The Colorado Infant Hearing Advisory Committee has representation (Attachment B, pg. 7-9) from statewide agencies, hospitals, diagnostic centers and early intervention program.  The task forces also have wide spread representation from hospitals, clinics, agencies and programs to develop guidelines and address issues.  Members of the Advisory Committee disseminate information through their respective professional organization such as the Colorado Chapter of the American Academy of Pediatrics, the Colorado Chapter of the American Academy of Otolaryngology and the Colorado Academy of Audiology.  Training workshops for audiologists and early interventionists are an ongoing collaboration between the Department of Education, the Colorado Academy of Audiology and the MCH Affiliated Physician Programs through JFK Partners.  HCP is currently investigating the opportunity to utilize telemedicine to provide expert pediatric audiology to local sites through JFK Partners and The Children’s Hospital.

Documentation of collaboration with other screening programs: Letters of support are included as Attachments K, pg. 142-151.  The Colorado Infant Health Advisory Committee has representation from CRCSN, the Newborn Genetic Screen Program and EPSDT.  These Programs are working already working to integrate their data systems on the statewide Integrated Registration Information System (IRIS).

Requirements for research project: N/A – See IRB Statement in Attachment L.pg.160-161.

Description of collaboration of EHDI program with blood spot and birth defect screening: Letters of support from CDPHE, HCP, CRCSN, EPSDT and the Newborn Genetic Screen are included as Attachments K.  These Programs have indicated a willingness to work collaboratively and modify the projects if necessary to accommodate multi-site projects for integration and standardization.  Please see description in Program and Methodology for how the above named data sets will be made to flow through the IRIS system which is currently used for data compilation and storage and used, to a limited degree, for case management.

STAFFING AND MANAGEMENT SYSTEM

Skills and experience to develop and implement an EHDI tracking and surveillance system: Resumes for key personnel are in Attachment J, pg.114-142; organizational charts are in Attachment I, pg. 106-113.

Bill Letson, M.D., CO-Principal Investigator, MCH Medical Consultant: Dr. Letson will provide oversight to the process of integration of the varied data systems into IRIS and development of the needed security arrangements for development of Internet platform databases and the eventual development of those databases.  He will also coordinate data analyses for HCP case management as well as analyses of the follow-up projects described for the disease entities identified by Newborn Genetic Screening.  Dr. Letson’s background is in Pediatrics, Infectious Diseases and Epidemiology/Public Health (see attached CV).

Vickie Thomson, M.A., CO-Principal Investigator, Coordinator Colorado Newborn Hearing Screening Program and State Audiology Consultant: Ms. Thomson will be responsible for activities of the Program Data manager to assure timelines are being met to integrate the data system.  She will provide education, training and maintain collaborative relationships within the CDPHE and agencies providing services and supports to families who have children that are deaf and hard of hearing.  Ms. Thomson has coordinated the Colorado Newborn Hearing Screening Program since it’s inception in 1992.  She has provided technical assistance to all Colorado birthing hospitals and has been instrumental in the design of the Colorado Infant Data Management Program.  She is currently the Coordinator on an MCH Grant which developed the Marion Downs National Center for Infant Hearing.  She provides extensive technical assistance to many state Title V programs in the development of comprehensive newborn hearing systems.  She is also the CO-PI on another MCH Grant recently awarded to the University of Colorado on newborn hearing systems.  In addition to her 60% FTE she will add a 20% FTE to manage the additional work as CO-PI on this project.

Arlene Stredler Brown, MA, Director of the Colorado Home Intervention Program: Ms. Brown is currently the CO-PI on the MCH grant described in Attachment F.  She has focused on appropriate intervention for very young children who are deaf and heard of hearing.  She has participated in research in this population and published several works on the topic.  She is currently the director of CHIP, a statewide early intervention program.  She will continue collaborative efforts at the state level between Part C, the Colorado Department of Education and the Colorado School for the Deaf and Blind to coordinate data efforts between agencies.  Ms. Brown will provide 5% in-kind to the coordination efforts between outside agencies.

Dinah Beams, CO-Hear Consultant: Ms. Beams coordinates activities for the CO-Hear Coordinators throughout the state.  She will be responsible for assuring that intake forms are submitted and input into the Colorado Infant Hearing Data Management System.  She will provide consultation for the development of the automated system described in the grant application.  She is currently working on the CDC grant described in Attachment F.  Ms. Beams will add an additional 10percent to her 40 percent FTE for this project.

Managerial ability to coordinate the tracking, surveillance, research and integration components of the project.

Program Data Manager (to be hired): This person will oversee the collaboration efforts between CRCSN, the Newborn Genetic Screening Program, the Colorado Infant Hearing Programs and EPSDT.  The program data manager will design and implement the various stages of automation at within the CDPHE utilizing the Integrated Registration and Information System (IRIS).  The program data manager will also work with the Colorado Hospital Association to design a system that will automate the Hospital Monthly Tracking and Follow-up Report for the newborn hearing screening program.  This person will design manuscripts and training manuals for use in state and to share with other states and territories.  The Program Data Manager will report to the CO-Pi’s.  This will be a 50 percent FTE.

Lisa Miller, MD, MSPH, Medical Epidemiologist, Director of Colorado Responds to Children with Special Needs: Dr. Miller is a board certified physician in General Preventive Medicine and an adjunct faculty member at the University of Colorado Health Sciences Center.  She has been Medical Director of Colorado Responds to Children with Special Needs and Principal Investigator of the CDC Birth Defects Cooperative Agreement since 1998.  Dr. Miller also contributes experience from other areas of public health, including surveillance for injuries and infectious diseases.  She has published articles on a variety of public health topics (see Attachment x).  Dr. Miller brings experience from public health surveillance for injuries, infectious diseases and the CRCSN Program.  She has published on a variety of topics.  Dr. Miller currently serves as the Co-PI for a CDC Fetal Alcohol Surveillance Project.  Dr. Miller will devote 5 percent in kind contribution to this project to coordinate efforts between CRCSN, EPSDT, the Newborn Genetic Program and the Colorado Newborn Hearing Screening Program.

April Montgomery, MHA, Prevention Projects Director.  Ms. Montgomery has worked with CRCSN as the Prevention Projects Coordinator providing technical assistance and training statewide.  She develops and conducts evaluation of the prevention programs.  Ms. Montgomery is currently the CO-PI for a CDC Fetal Alcohol Surveillance Projects.  She will provide an in kind contribution of 5 percent.

Expertise in abstracting screening, identification intervention records. 

Laura Taylor, Coordinator, Newborn Genetic Screen: Ms. Taylor is currently responsible for tracking infants identified as being at risk for genetic and congenital diseases by the Newborn Screening Program to ascertain that they receive appropriate and timely confirmatory testing, diagnosis and treatment.  Ms. Taylor designs and maintains registries of children diagnosed with disease through the newborn screening program.  Ms. Taylor will continue collaboration with the newborn screening laboratory and consultant physicians in designing protocols for follow-up.  She will contribute 5% in kind to support the collaboration between CRCSN, EPSDT, the Newborn Hearing Screening Program and the integration of data systems into IRIS.

Expertise in epidemiological methods, public health surveillance data, management and computer programming.

Bill Letson, M.D., CO-Principal Investigator: As noted in section 6a, Dr. Letson has a background in epidemiologic analyses and surveillance and can coordinate the effort to analyze the data requiring analysis as a result of this project.  Our budget provides for the necessary programming and this activity will coordinate by Ann McNulty who currently supervises the development and ongoing revisions of IRIS.

Ann McNulty, Data Systems Support Manager, Family and Community Health Services Division: Ms. McNulty is responsible for oversight of all data system needs for the division including asset management and long-range planning, staff development.  She oversees development of software for statewide distribution to local public and private public health entities.  She manages the Integrated Registration and Information System (IRIS) which this project proposes to use for integration and data flow between CRCSN, EPSDT, Colorado Newborn Hearing Screening Program and the Newborn Genetic Screening Program.  She will serve as the liaison to Information Technology Systems.

ORGANIZATIONAL STRUCTURE

Adequacy of the organization – structure, facilities/space/equipment to carry out the activities of the project: Organization charts are located in Attachments I, pg. 106-113.  They demonstrate the organizational structure of the CDPHE; the organizational structure of departments collaborating on this project; HCP organizational chart; Statewide services chart for hearing services; map of Colorado and counties within Regional HCP offices; Logical Network Overview of the computer systems.  The budget justification also demonstrates the in-kind staff and services that will be providing additional supports for this project.

HUMAN SUBJECTS REQUIREMENTS: Form OMB No.0925-0418 on page

References

1. American Academy of Pediatrics Policy Statement: Newborn and Infant Hearing Loss: Detection and Intervention (RE9846), Pediatrics, 103 (2), 527-530.
2. Joint Committee on Infant Hearing Position Statement 2000, ASHA, www.asha.org, June 12, 2000.
3. National Institutes of Health Consensus Development Conference Statement: (1993) Early Identification of Hearing Impairment in Infants and Young Children, March 1-3,1993
4. National Institute on Deafness and other Communicative Disorders. (1989) A report on the task force on the national strategic research plan, Bethesda, MD: National Institutes of Health.
5. Yoshinaga- Itano, C., Thomson, V., Coulter, D. The Colorado Newborn Hearing Screening Program: Effect on Speech and Language Development for Children with Health Loss, in press, Journal of Perinatology.
6. Yoshinaga-Itano, C., Sedey, A.L., Couler, D.K., Mehl, A. Language of Early and Later Identified Children with Hearing Loss. Pediatrics. 102:5
7. U.S. Department of Health and Human Services (HHS)(2000) Healthy People 2010: National Health Promotion and Disease Prevention Objectives. Washington, D.C.: Public Health Service Objective 28.11.